GranuFlo, NaturaLyte Maker Faces Center Closure Following Patient Deaths, Poor Infection Control Standards

GranuFlo_DialysisA dialysis center owned by Fresenius Medical Care North America has shut down following infection-related deaths and hospitalizations.

The Bessemer Kidney Center is one of one dozen dialysis centers in Alabama that are owned by Fresenius Medical Care. This center was shut down earlier this month following two patient deaths and other patient hospitalizations that occurred over a matter of days, according to AL.com. The U.S. Centers for Disease Control and Prevention (CDC) and the Alabama Department of Public Health are investigating.

The March 15, 2012 inspection revealed that the Bessemer Center failed to meet a variety of infection control standards, among other issues, according to AL.com. “Based on the observation, facility policy review and staff interview, it was determined the facility failed to ensure the patient care staff wore gloves and washed hands appropriately during patient care,” according to the inspection conducted by the state health department for participation in the Medicaid and Medicare programs. The deficiencies, according to the report, “had the potential to affect all patients served by the facility.”

Eleven other Fresenius dialysis centers in Alabama, alone, have been cited with deficiencies over a two-year period in these health department surveys: Fresenius Medical Care in Fairfield, Foley, Alexander City, Discovery Dialysis Center (Huntsville), Eastern Shore (Fairhope), Gardendale, Opelika, Prattville, Tuskegee, South Alabama (Mobile), and Valley Creek (Selma). Fresenius operates centers in the United States, Canada, and Mexico, according to AL.com.

This is not the first time Fresenius has been accused of serious issues associated with its dialysis centers. Recent lawsuits accuse Fresenius Medical Care of deliberately concealing potentially fatal problems with its now-recalled GranuFlo and NaturaLyte products, which were approved to lower the acidity of patients’ blood during dialysis treatments. The lawsuits allege that patients’ treated with these products tested with a high concentration of acetone, which led to abnormally high levels of bicarbonate in their blood. This led to fatal heart problems and strokes, according to prior court documents.

A judicial panel recently decided that the lawsuits will be consolidated into a federal court hearing. Fresenius Medical Care now faces hundreds of claims; many more are expected. Massachusetts is the chosen venue.

Lawsuits filed over the acid concentrate products allege that GranuFlo or NaturaLyte can lead to metabolic alkalosis, causing a number of potentially fatal complications. The lawsuits also allege that GranuFlo and NaturaLyte were defectively designed and that Fresenius Medical Care neglected to warn of the risks related to these hemodialysis products.

According to a The New York Times article published last June, the U.S. Food and Drug Administration (FDA) began investigating Fresenius Medical Care to learn if they had or had not violated federal regulations by failing to warn consumers about the potentially fatal risks associated with use of GranuFlo and NaturaLyte. The Times reported that the GranuFlo and NaturaLyte dialysis products raised safety concerns following news about an internal memo dated November 4, 2011 that warned that 941 hemodialysis patients suffered from cardiac arrest in Fresenius facilities in 2010. That memo was issued to Fresenius facilities; however, the information was not made available to the public until the firm was prompted to do so by the FDA.

Last June, the FDA deemed a GranuFlo and NaturaLyte recall a Class I, warning that the products, which received agency approval in 2003, may lead to high levels of bicarbonate in patients undergoing hemodialysis when inappropriately prescribed. The agency said that these increased levels can lead to metabolic alkalosis, a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia. If not appropriately treated, cardiopulmonary arrest may occur. A Class I recall is the agency’s most serious designation and indicates that the recalled product may cause serious adverse health consequences, including death.

 

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